BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT FLEX

    MDR report key: 7231893 · Received January 31, 2018

    Report

    Report Number
    3011393376-2018-00505
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    January 19, 2018
    Report Date
    April 13, 2018
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SELF-ADHESIVE OF THE INFUSION SET WAS NOT STICKING WELL ENOUGH. THE CANNULAS WERE FALLING OFF ALMOST AS SOON AS THE PATIENT APPLIED THEM AND SHE WENT THROUGH ABOUT 6 INFUSION SETS FROM THE SAME BOX. NO ADVERSE EVENT WAS REPORTED. THE PATIENT PROVIDED AN INVALID LOT NUMBER (1180469) WITH EXPIRATION DATE (02/2019). THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75225 ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR